The following is the summary of medical device technical review in March 2024:
Submissions Overview | In Process of Technical Review:1371 |
Technical Review Completed:1254 | |
Submissions Accepted | Document Review:1423 |
Submissions Accepted:2140 | |
Filing Modification :801 | |
Import Class I Device Filing:242 | |
RFEs and Responses to RFEs | RFE released: 607 |
RFE Response Accepted: 639 | |
Advisory Meetings | Meeting initiated: 12 |
Meeting conducted: 16 | |
PAI (Preapproval QMS Inspection) | PAI Initiated: 319 |
PAI Completed: 205 | |
Special review of innovative medical devices | Submission: 26 |
Organize expert review meetings: 44 | |
Complete review: 48 | |
Priority approval of medical device review | Submission:7 |
Review Completes: 5 |